Informed Consent for Use of Stored Specimens
Part 1
Dr. Samantha Smith and Dr. Joyce Jones have collaborated on
an epidemiologic study to identify determinants of preterm
birth (delivery before 37 completed weeks of gestation). Over
five years, the project team recruited 10,000 women into the
study from prenatal care clinics in South Carolina. The study
participants provided genital tract, blood and urine specimens,
all of which were frozen and stored. They collected a great
deal of other information through interviews with the
participants and review of their medical charts, including
social, demographic, health behavior and health history
information.
All study forms and specimens were coded with identification
numbers rather than the women's names. The links between the
identification numbers and names were kept locked up and
separate from all other study materials.
The consent form signed by the women in the study described
in a general way the analyses planned on the biological
specimens. For example, genital tract specimens were to be
analyzed for the presence of infections, blood samples were to
be analyzed for levels of different vitamins, and urine was to
be checked for cotinine (a marker of exposure to cigarette
smoke).
It has now been five years since the end of data collection
for the study, and Smith has become very interested in studying
potential genetic causes of preterm delivery. She realizes that
this cohort of women, from whom a great deal of information has
been collected, provides a unique opportunity to conduct an
investigation of her hypothesis with minimal additional work or
funding.
Smith is eager to proceed with a genetic analysis using the
participants' stored blood specimens. However, Jones is
concerned. "Sandy, the consent form that these women signed did
not mention the possibility that we might do this genetic
analysis. We'll have to contact them again and ask for their
permission."
Smith thinks that contacting the women would be too
difficult. "But, Joyce, that's unreasonable. You know the
logistical challenges we face in trying to find these women --
some of the participants were recruited as long as a decade
ago. We should just go ahead with the analysis. It's not that
big a deal. It wouldn't make sense to pass up this
opportunity."
Discussion Questions
- Are Smith and Jones obligated to recontact the
participants to ask for permission to do a genetic analysis
using their specimens?
Part 2
Smith thinks of a way around having to ask the women for
permission to do the additional analysis. "Joyce, how about
making the specimens anonymous by destroying the links between
the names and the identification numbers before we proceed with
the analysis? Then we won't need to ask for consent; in fact,
we won't even be able to."
Jones doesn't agree. "No, I still think we need to recontact
them to ask for their permission to analyze their specimens.
Besides, if we destroy the links between the names and numbers,
that would interfere with conducting further follow-up studies.
And what if we want to give them the results of our
analyses?"
Discussion Questions
- Should the investigators destroy the links between the
names and identification numbers before proceeding with the
genetic analysis?
- If they do decide to destroy the links, are they still
obligated to recontact the subjects first to ask their
permission to do the additional analysis?
- Do they have an obligation to inform the women of any
results of the genetic analysis?
Part 3
Suppose that when the study was originally conceived, Smith
and Jones had foreseen the possibility of wanting to conduct
further analyses on the subjects' specimens. Therefore, they
had included in the consent form the following statement: "If
any specimens remain, additional tests may be done for research
purposes such as tests to look at factors in your blood that
might affect pregnancy or health."
Discussion Questions
- Does the statement in the consent form provide adequate
informed consent regarding the planned genetic analysis?